Ambulatory Surgery, Anesthesia, Postoperative Complication, Postoperative Pain
Conditions
Keywords
postoperative pain, ambulatory surgery, general anesthesia, anesthesia consultation, post-op prescription
Brief summary
This study evaluates the comparison of the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia preoperative clinic and a group with postoperative prescription.
Detailed description
The ambulatory surgery increased over the last twenty years in France. The management of home pain after ambulatory surgery is a major challenge because it is the principal complication after day surgery with several consequences: nausea and vomiting, chronic pain, functional impairment with handicap, sleeping troubles, extra-hospital consultation. Management of home pain remains currently could be performed in ambulatory surgery. The French Society of Anesthesiology recommends to deliver pre-surgical prescription during the preoperative anesthesia clinic but this guideline is not bases on evidence in the literature. Also, we have previously shown in a retrospective non-randomized work a decrease of postoperative home pain in patient with general anesthesia. The main objective of this controlled and comparative study is to compare the incidence of postoperative home pain after ambulatory surgery with general anesthesia between a group with pre-surgical prescription delivered during anesthesia consultation and a group with postoperative prescription.
Interventions
OTHERComparison between pre-operative prescription and post-operative prescription
The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a randomized, prospective, study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any major ambulatory surgery patient with general anesthesia.
Exclusion criteria
* Pregnancy. * Minor patient. * ASA score \> 3. * lack of general anesthesia. * General anesthesia combined with locoregional anesthesia. * Contraindication to ambulatory surgery. * Chronic pain. * chronic analgesic consumption. * no indication of non steroidal anti-inflammatory drug, paracetamol with codeine and morphine. * Active or old drug addiction. * Cognitive disorders or dementia. * Serious psychiatric disorders. * Patient under curatorship or tutorship. * No social protection * Misunderstanding of the French language * Patient participating in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early home pain after ambulatory surgery | 24 hours after ambulatory surgery | The primary outcome is the incidence of at least one home pain experience with intensity greater than 3 on a scale from 0 to 10 within 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intense painful experience during hospitalisation | Day 1 | Incidence of a pain experience at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 during hospitalisation. |
| Low painful experience during hospitalisation | Day 1 | Incidence of a pain experience at mobilization or at rest of intensity lower than 3 on a scale from 0 to 10 during hospitalisation. |
| Low home pain experience | 24 hours after ambulatory surgery | Incidence of a pain experience at mobilization or at rest of intensity lower than 3 at home on a scale from 0 to 10 within 24 hours after surgery |
| Intense home pain experience | Within 7 days after ambulatory surgery | Incidence of home pain at mobilization or at rest of intensity greater than 3 on a scale from 0 to 10 within 7 days after surgery. |
| Adherence to analgesic treatment | Within 7 days after ambulatory surgery | Adherence to analgesic treatment in relation to prescription (yes or not) |
| Patient's satisfaction | Within 7 days after ambulatory surgery | Patient's satisfaction with prescribed treatment (scale from 0 to 10, satisfying opinion defined by a score greater than 8) |
| Use of morphine analgesics | Within 7 days after ambulatory surgery | Incidence of morphine analgesic use |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVincent COMPERE, Pr
University Hospital, Rouen
Outcome results
None listed